| | Class 2 Device Recall P.F.C. |  |
| Date Initiated by Firm | May 26, 2005 |
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| Date Posted | August 12, 2005 |
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| Recall Status1 |
Terminated 3 on December 02, 2005 |
| Recall Number | Z-1187-05 |
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| Recall Event ID |
32192 |
| 510(K)Number | K033272 |
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| Product Classification |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
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| Product | Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 15 mm; Ref 1581-24-015. |
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| Code Information |
Lots Y58F14 and YY5BH4. |
Recalling Firm/
Manufacturer |
Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
|
| For Additional Information Contact |
800-366-8143 |
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Manufacturer Reason
for Recall | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. |
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FDA Determined
Cause 2 | Other |
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| Quantity in Commerce | 18 |
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| Distribution | Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = JWH
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